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Snapshot 2026-10-27 · Link to EUDAMED

Healgen Scientific Limited Liability Company

SRN US-MF-000018839

manufacturer · Houston, TX, US · 30 devices

3818 Fuqua Street, 77047

Devices

NameUDI-DIClassBadge
Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)00810173656900Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Hand-Held Immunofluorescence00816490028444Class A
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)00816490028475Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)00816490028482Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Immunofluorescence Analyzer00816490028192Class A
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Immunofluorescence Analyzer00816490028437Class A
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)00810173656818Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)00810173656825Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)00810173656832Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)00810173656849Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)00810173656856Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)00810173656863Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Mini Immunofluorescence Analyzer00810173654708Class A
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Mini Immunofluorescence Analyzer00816490028420Class A
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Multiplex Fluorescent Analyzer00810173653022Class A
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)00810173656979Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)00810173656986Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)00810173656931Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)00810173656948Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method)00810173656924Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method)00810173656962Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method)00810173656917Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)00810173656887Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Quantitative Analysis Kit for Six Cytokines (Flowcytometry Fluorescence Method)00810173656955Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)00810173656894Unknown class
No Certificate Found

Snapshot 2026-10-27 · Link to EUDAMED

Healgen Scientific Limited Liability Company (SRN US-MF-000018839) — registered devices | UDI Compass